Dose-Tolerability Titration Study to Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)

NCT00592774 | Completed Phase 2 Results

• 1 other identifier: E2007-A001-218
• Study Type: interventional
• Target: 146
• Locations: 2 countries
• Sites: 47

Brief Summary

The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in patients with Post-Herpetic Neuralgia (PHN).

Conditions

Neuralgia

Keywords

Post-Herpetic Neuralgia; PHN)

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)

  Average pain scores are based on pain intensity (11-point Likert-type numerical scale, where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.

  Baseline and Week 15

• Responder Rate: Subjects With at Least 30 Percent Reduction in Pain

  A responder was a participant with at least 30 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.

  Baseline and Week 15

• Responder Rate: Subjects With at Least 50 Percent Reduction in Pain

  A responder was a participant with at least 50 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.

  Baseline and Week 15

• Change From Baseline in Average Pain Scores by Week

  Change from baseline in average pain scores by week based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain scores were calculated as the average of available scores in each week, and were reported by treatment group.

  Week 1 through Week 16

Secondary Outcomes (6)

• Change From Baseline to Week 15/EOT in Average Sleep Interference Scores

  Baseline and Week 15

• Patient Global Impression of Change (PGIC) at Week 15/EOT

  Week 15

• Clinician Global Impression of Change (CGIC) at Week 15/EOT

  Week 15

• Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)

  Baseline and Week 15

• Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)

  Baseline and Week 15

Study Arms (5)

Placebo Cohort 1

PLACEBO COMPARATOR

Drug: Placebo

Perampanel Cohort 1, 3-week Titration

EXPERIMENTAL

Drug: E2007 (perampanel)

Placebo Cohort 2

EXPERIMENTAL

Drug: Placebo

Perampanel Cohort 2, 1-week Titration

EXPERIMENTAL

Drug: E2007 (perampanel)

Perampanel Cohort 2, 2- Week Titration

EXPERIMENTAL

Drug: E2007 (perampanel)

Interventions

E2007 (perampanel) DRUG

2 mg titrated up to 8 mg maximum; taken once daily.

Also known as: perampanel

Perampanel Cohort 1, 3-week Titration; Perampanel Cohort 2, 1-week Titration; Perampanel Cohort 2, 2- Week Titration

Placebo DRUG

2 mg titrated up to 8 mg maximum; taken once daily.

Placebo Cohort 1; Placebo Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included, patients must meet the following:
• Provide written informed consent, prior to entering the study or undergoing any study procedures.
• Male and female patients ≥18 years of age. Females should be either of nonchildbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception. Acceptable contraception includes: abstinence, a barrier method plus spermicide, or intrauterine device \[IUD\]. Those females using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD). Contraceptive use must start at least 1 month before Visit 1, be practiced throughout the entire study period, and continue for 1 month after the end of the study. They must also have a negative serum beta-human chorionic gonadotropin (β-hCG) at Visit 1, and a negative urine pregnancy test at Baseline Visit 2.
• PHN of at least 6 months duration; the onset of PHN is defined as the time from healing of herpes zoster skin lesions.
• Pain over the past 6 months, and not in a clinically identifiable improving or worsening trend, based on medical history.
• Score of ≥ 40 mm on the visual analog scale (VAS) of the short form McGill Pain Questionnaire (SF-MPQ) at both Visit 1 and Baseline (Visit 2 prior to randomization).
• Have completed the patient diary for at least 6 of the 7 days prior to Visit 2 (Baseline).
• Average daily pain score of ≥ 4, on 11-point Likert scale during the 7 days prior to randomization \[from the diaries\].
• Reliable and willing and able to cooperate with all study procedures, including the following examples:
• Accurately entering the diary on a daily basis
• Returning for study visits on the required dates
• Accurately and reliably reporting symptoms (including treatment-emergent signs and symptoms)
• Taking study drug as required by protocol
• Be on stable analgesic treatment (same medication(s)) or stable nonpharmacological pain treatment for at least 4 weeks prior to Visit 1 and remain on this stable treatment throughout the study. Nonpharmacologic pain treatment includes the following:
• relaxation/hypnosis

You may not qualify if:

• Patients with any of the following are to be excluded:
• Any condition that could interfere with the conduct of the trial or confound efficacy evaluations including the following examples: pain or neuropathy from another cause (including painful diabetic neuropathy), such as central pain, radiculopathy, painful arthritis, etc.
• Motivation by secondary gain, or where there is a negative-incentive to achieving pain and functional relief (eg, litigation). This will be determined from the medical history and is at the discretion of the investigator.
• Inability to cooperate with protocol, for any reason.
• Clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, CNS, psychiatric, endocrine, or immunologic, including patients with any of the following broad disease categories:
• Systemic infections (eg, human immunodeficiency virus \[HIV\], hepatitis, tuberculosis \[TB\], syphilis); lack of appropriate medical history of these conditions is acceptable,
• History of past (within the past 12 months) or present drug or alcohol abuse as per the Diagnostic and Statistical Manual - 4th Edition (DSM IV) criteria,
• History of acute coronary syndrome within the past 12 months,
• Active cancer within the previous 5 years (the exception is fully treated, non-melanoma skin cancer such as basal cell carcinoma),
• Systemic chemotherapy or immunotherapy within the past 5 years,
• History of major depression, bipolar disease, psychosis or suicidal ideation or attempts within the past 5 years,
• History of major systemic allergy such as anaphylactoid reactions or Stevens-Johnson syndrome (however, patients with limited allergies such as contact dermatitis or minor allergy to penicillin are acceptable).
• Any of the following laboratory abnormalities at Visit 1:
• Clinically significant ECG abnormality, including prolonged QTc (defined as QTcB \> 450 msec),
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal (ULN),

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (47)

Unknown Facility

Peoria, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Boulder, Colorado, United States

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Denver, Colorado, United States

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Milford, Connecticut, United States

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Boca Raton, Florida, United States

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Bradenton, Florida, United States

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Daytona Beach, Florida, United States

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Delray Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Kissimmee, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Orlando, Florida, United States

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Palm Beach Gardens, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Sunrise, Florida, United States

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Tampa, Florida, United States

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Pain and Rehabilitation Clinic of Chicago

Chicago, Illinois, 60610, United States

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Chicago, Illinois, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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West Yarmouth, Massachusetts, United States

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Southfield, Michigan, United States

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Missoula, Montana, United States

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Las Vegas, Nevada, United States

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Brooklyn, New York, United States

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High Point, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Kettering, Ohio, United States

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Bensalem, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Dallas, Texas, United States

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Kelowna, British Columbia, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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MeSH Terms

Conditions

Neuralgia; Neuralgia, Postherpetic

Interventions

perampanel

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Allison Mann, MD

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 14, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: February 15, 2013
• Results First Posted: February 15, 2013

Record last verified: 2013-02

Locations

CA (5); US (42)